Investor Presentation January 2018 D i s c l a i m e r This - - PowerPoint PPT Presentation

investor presentation
SMART_READER_LITE
LIVE PREVIEW

Investor Presentation January 2018 D i s c l a i m e r This - - PowerPoint PPT Presentation

Investor Presentation January 2018 D i s c l a i m e r This confidential document and the information contained in this document (the Presentation ) constitutes neither an offer for sale or subscription nor a solicitation of a purchase or


slide-1
SLIDE 1

January 2018

Investor Presentation

slide-2
SLIDE 2

Page 2

D i s c l a i m e r

This confidential document and the information contained in this document (the “Presentation”) constitutes neither an offer for sale or subscription nor a solicitation of a purchase or subscription order for Cellnovo shares in any country. No offer of shares is made, or will be made in France, before obtaining a visa from the Autorité des Marchés Financiers (the “AMF”) on a prospectus comprising a registration statement (document de base) and securities note (note d’opération) that will be submitted to the AMF. In particular, this Presentation does not constitute an offer for sale of securities or any solicitation of a purchase or subscription order for securities in the United States or by U.S. persons (as such terms are defined in Regulation S under the U.S. Securities Act of 1933, as amended (the “Securities Act”). Cellnovo shares may be only offered or sold in the United States pursuant to an effective registration statement under the Securities Act or under an exemption from the registration requirement of the Securities Act. Cellnovo shares have not been and will not be registered under the Securities Act, and Cellnovo has no intention of making any public offering of its shares in the United States. This Presentation does not constitute a prospectus within the meaning of Directive 2003/71/EC of the European Parliament and of the Council of November 4, 2003, as amended, in particular by Directive 2010/73/EC of the European Parliament and of the Council of November 24, 2010 (the “Prospectus Directive”). Its dissemination may be governed by specific regulations in certain countries. Persons in possession of this Presentation should therefore acquaint themselves and comply with any local restrictions. No action has been taken or will be taken for the purpose of enabling a public offering of securities requiring the publication by Cellnovo of a prospectus in a Member State other than France. Consequently, the Cellnovo shares may not and will not be offered in any Member State other than France, except in accordance with the exceptions set forth in Article 3.2 of the Prospectus Directive or in other cases not requiring publication by the Company of a prospectus pursuant to Article 3.2 of the Prospectus Directive or other applicable regulations in that Member State. Regarding the United Kingdom, this Presentation has not been approved by an authorised person in accordance with Section 21 of the Financial Services and Markets Act 2000 and therefore it is intended to be delivered solely and for information purposes only to persons who (i) are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as currently in effect, hereinafter the “Financial Promotion Order”), (ii) are referred to at Article 49(2) (a) to (d) (“high net worth companies, unincorporated associations, etc.”) of the Financial Promotion Order, (iii) are outside the United Kingdom, or (iv) are persons to whom an Presentation or incitement to engage in investment activities (within the meaning of section 21 of the Financial Services and Markets Act 2000) in the context of the issuance or disposal of securities may legally be extended, directly or indirectly (all such persons being collectively named “Authorised Persons”). This Presentation may not be used by any person who is not an Authorised Person. By accepting this Presentation and not immediately returning it, the recipient represents and warrants that they are a person who falls within the above description of persons entitled to receive the Presentation.

slide-3
SLIDE 3

Page 3

A M a n a g e m e n t Te a m W i t h A S u c c e s s f u l Tr a c k R e c o r d

  • Dr. Sophie Baratte

CEO

20 years of experience in Sales & Marketing functions in the medical technology sector, including Sorin Group

Served as CEO of CIT, General Manager for the In Vitro Diagnostics branch of Johnson & Johnson in France and as senior EMEA Sales & Marketing Director for Lifecell Engineer, Ph.D. in biotechnology, MBA

Erwan Martin CFO

20 years of experience in finance and biotechnologies

Former CFO of Genomic Vision, co-founded Cytomics Pharmaceuticals, served as project manager at Syndex

  • Dr. Julian Shapley

CSO, Founder

NASA experience

Founded Cellnovo in 2008 MBA at Warwick Business School Ph.D. in micro-fluidics at Cardiff University

John Brooks Chairman

Served as CEO and Founder of Insulet, and as CEO of Joslin Diabetes Center

Over 30 years of experience in the medical device industry in diabetes

Javaid Masoud CTO

Served at Medtronic and at Sorin Group in Senior director roles for wireless technologies, embedded firmware development for implantable cardiac defibrillators, wireless communication protocol, embedded firmware for implantable devices, and software for external instruments

slide-4
SLIDE 4

Page 4

C e l l n o v o i n a N u t s h e l l

The first connected, all-in-one Diabetes Management System

  • 1. North America+ Main European countries, Medtronic's, Investor Conference, June 2014
  • Cellnovo develops and commercialises a disruptive insulin micro-pump
  • A $2.5Bn market: Growing and well-reimbursed

Focused on Type 1 diabetes with a potential for larger Type 2 market

  • Addressing clear market needs

The only real-time data device, for better patient outcomes

  • Unique accuracy and safety features
  • A clearly defined global strategy supported by strategic partners
  • Roche: Contract for Blood Glucose Measurement
  • Flex: Manufacturing partner
  • Air Liquide: Major distribution partner
  • Road map towards Artificial Pancreas and smartphone
  • IPO on Euronext Paris in July 2015
  • €20m loan agreement with the EIB – July 2017
  • €17.5m capital raise from healthcare investors – July 2017
slide-5
SLIDE 5

Page 5

Ty p e 1 D i a b e t e s : A l a r g e m a r k e t , w e l c o m i n g i n n o v a t i o n

T1 Patient Market* MDI Tubed Pump Micro-Pump US % Patient Use

70% 26% 4%

EU % Patient Use

85% 12% 3%

Market Size

$2 B $400 M

Growth Rate

<5% 40%

Market Players

Pumps are providing short and long-term benefits to patients, despite low penetration

* Source: Company estimates

slide-6
SLIDE 6

Page 6

C e l l n o v o : A G a m e C h a n g e r f o r I n s u l i n P u m p Te c h n o l o g y

The perfect combination between a new generation of micro-pump and a mobile handset to allow the best accuracy and a 24/7 health remote monitoring Intuitive operation, wireless connectivity, real-time tracking, and Bluetooth and Android-enabled = All industry firsts

  • The insulin reservoir
  • Pumping mechanism
  • Occlusion sensor
  • High resolution, full-colour touchscreen
  • GSM Modem
  • Micro SD port
  • Apps-friendly
  • Roche BG Meter integrated
  • Bolus calculator
  • Real-time data
  • Automated capture of data

and transmission

  • Analytics and trends
  • Stakeholders access
  • Pump microprocessors and

memory

  • Rechargeable battery
  • Accelerometer
  • Precision reservoir sensor

Insulin Cartridge Mobile Handset Online Wireless Durables Disposables

slide-7
SLIDE 7

Page 7

  • Informing payers of compliance to

treatment

  • Lower pricing compared to other

micro-pumps

C e l l n o v o , a B r e a k t h r o u g h i n I n s u l i n D e l i v e r y, f o r a l l S t a k e h o l d e r s Driving Savings

  • Ideal pump for lifestyle,

wearability, comfort

  • High demand from patients
  • E-connected for family’s peace of

mind

  • Interoperability with connected

devices (CGM, BGM, activity trackers, e-watches)

  • Real time information to drive better

patient outcomes

  • Unrivalled accuracy and safety of

drug delivery in micro-pumps

Cost Effective Patients’ support

  • Effective patients’ communication and trouble shooting,

based on real time back-end data

Freedom and peace of mind

The only e-connected, accurate, wearable insulin micro-pump

slide-8
SLIDE 8

Page 8

C e l l n o v o , t h e F i r s t C o n n e c t e d M i c r o - P u m p A l l o w i n g M a x i m u m I n t e r o p e r a b i l i t y i n t h e D i a b e t e s E c o s y s t e m

ALGORITHMS CONTINUOUS GLUCOSE MONITORS FOOD LIBRARIES WEARABLES, HEALTH MONITORS BLOOD GLUCOSE METERS

Other Dataflows Cellnovo Dataflow

Dexcom PATIENT

slide-9
SLIDE 9

Agenda

1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials

slide-10
SLIDE 10

Page 10

C e l l n o v o B e n e f i t s C o m p a r e s P o s i t i v e l y t o t h e o t h e r M i c r o - p u m p s

For additional comfort Better outcomes and peace of mind Better COGS and eco-friendly device High quality of treatment A key feature for all Intuitive usage Bluetooth and Android-enabled

E-health in real time Higher accuracy of delivery Disposable plastics Detachable Enhanced safety Touchscreen colour Handset

slide-11
SLIDE 11

Page 11

T h e C e l l n o v o S y s t e m : T h e M o s t A c c u r a t e M i c r o - p u m p i n D r u g D e l i v e r y

Not all micro-pumps are equal

Cellnovo: 2-part pumping system

  • 100,0%
  • 50,0%

0,0% 50,0% 100,0% 50 100 150 200 Flow rate error Observation duration (minutes)

Omnipod

Percentage error vs. observation window (Time based).

  • 100,0%
  • 80,0%
  • 60,0%
  • 40,0%
  • 20,0%

0,0% 20,0% 40,0% 60,0% 80,0% 100,0% 50 100 150 200 Flow rate error Observation duration (minutes)

Cellnovo

Percentage error vs. observation window (Time based).

Cardiff University, UK- Jenna L Bowen and Chris J Allender - Trumpet curves for a typical Cellnovo and OmniPod™ patch pump device showing the maximum positive and maximum negative flow rate error (green solid lines) and the average flow rate error (red dotted line) for 2, 5, 11, 19 and 31 pulses.

  • Accuracy of the wax-powered

pumping mechanism

  • Superiority of durable electronics

and drop-by-drop alterations control system

A difference explained by the design

Traditional micro-pump: Fully disposable, all-in-one system

  • Low cost, low

sophistication electronics

  • Flat rate pumping

mechanism

slide-12
SLIDE 12

Page 12

A c c u r a c y, t h e R e s u l t o f a U n i q u e M e c h a n i s m o f D e l i v e r y

The core technology: The paraffin wax micro-actuator

The expansion of heated paraffin wax serves as a mechanism to push a piston against a membrane, thereby creating a pumping mechanism OCCLUSION VALVE INLET VALVE OUTLET VALVE PUMPING CHAMBER GEARING PISTON DIODE

WAX

Cool Wax Heated Wax

After melting

+15%

Volumetric Expansion (%) Solid phase Liquid phase

IP protected until 2035

Wax Micro Actuator Displacement Sensor Micro- Valve Cyber security

slide-13
SLIDE 13

Page 13

S a f e t y S y s t e m s O n B o a r d

Product Time to Occlusion Alarm Missed Insulin (U) Cellnovo 24.12 2.02 Omnipod Gen2 41.35 3.46 Medtronic 57.49 4.82 Animas Vibe 44.09 3.68 Roche Spirit Combo 28.47 2.39

Best-in-class in case of occlusion

Intelligent Delivery System

Delivery Sensor

Automatic release mechanism Temperature risk alarm

Insulin delivery alarms

72-hour Expiry alarm

Encryption

The pump’s electronics, designed to bring safety to a new level

slide-14
SLIDE 14

Agenda

1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials

slide-15
SLIDE 15

Page 15

C o n s u m a b l e s : L a r g e - s c a l e P r o d u c t i o n w i t h F l e x

  • High volume automation and

manufacturing

  • Stacked basic components,

suitable for high cavity moulding

Flextronics’ mass production Cellnovo’s limited production Ongoing transfer from Cellnovo to Flex

IC capacity

Per production line

Capacity pa

600,000

IC capacity Capacity pa

50,000

From Cellnovo’s R&D workshop To Flex Austria Followed by production in Romania Design to cost to further optimise COGS

1 2 3 4 1 2 3 4

Increasing volumes of consumable parts Reducing COGS

slide-16
SLIDE 16

Page 16

D u r a b l e E l e m e n t s : A s i m p l e p r o d u c t i o n r o a d m a p

The mid-term manufacturing strategy favours outsourcing Cellnovo to remain lean with low overheads

Relatively low production volumes are required: Each patient needs 2 pumps and 1 handset The manufacturing roadmap will aim at decreasing COGS by 2-fold

2018 : Replaced by a smartphone Assembled by Cellnovo

Production strategy

2017: Assembled by Cellnovo

  • PCB made by Sony

The Micro-Pump The Handset

2019: Outsourced

*

* Picture non-contractual

  • PCB made by Sony
slide-17
SLIDE 17

Agenda

1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials

slide-18
SLIDE 18

Page 18

E a s y t o A c c e s s w i t h F a v o u r a b l e R e i m b u r s e m e n t

Cellnovo micro-pump has access to public funding across many geographies

Market Durables 3 Day disposables

USA $4,500 $15 UK £2,750 £11.30 France €2,340 €16.65 Italy €4,800 €18 Germany €2,800 €12

  • 1. Source : Company

Simple market access based on existing codes

  • Market access provided by CE marking
  • Already CE marked
  • Market access provided by 510K clearance
  • Expected in 2018
  • Reimbursement using traditional pumps’ codes
  • Established codes in each countries
  • Describing a durable pump and a consumable

part

  • Reimbursement using CPT code 1

Tube pumps’ prices

slide-19
SLIDE 19

Page 19

C e l l n o v o ’ s C o m m e r c i a l R o a d M a p

A network with direct sales forces and experienced distributors

2014

System introduction through proprietary sales force in the UK and France

2016

Expansion into other major European countries using specialized distributors : The Netherlands, Italy

2017

Expansion into Spain, Ireland, Greece, Israel, ..

2016

510k submission

2018/2019

Launch in the US Launch in Canada First countries in Latin America

2017 Launch in Australia/NZ 2018 Launch in Hong Kong 2019/2020

Launch in India Launch in China

Europe USA China/Asia

Direct Distribution (UK, France) Air Liquide Santé network: Benelux, Italy Expansion to new European countries

slide-20
SLIDE 20

Agenda

1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials

slide-21
SLIDE 21

Page 21

C e l l n o v o , t h e S y s t e m o f C h o i c e f o r A r t i f i c i a l P a n c r e a s

  • US well-proven

program, with 215,501 hours of clinical trial

  • Continuous work with three partners to reach

strategic objectives:

  • Best in class AP system on a wearable

pump

  • Recognised manufacturer of the

system

  • Maximise business value for the

Company

All projects with Dexcom G5

  • French atomic center

mathematicians and 12 major teaching hospitals in France

CONT INUOUS GL UCOSE SE NSOR CONT R OL AL GOR IT HM
  • Automatic adjustments of insulin

delivery

  • Based on expert software and

Continuous Blood Glucose reading

  • Un-Equaled Quality of Life
  • Less Deadly Complications

The potential to be the #1 Artificial Pancreas using a micro-pump

Artificial Pancreas, the next breakthrough in diabetes management Cellnovo‘s partners Commercial strategy

  • European consortium of

leading UK and European universities and companies

  • n artificial intelligence
slide-22
SLIDE 22

Page 22

R & D R o a d m a p

A steady flow of continuous updates and developments

2016 Roche BGM PEPPER – EU sponsored Consortium on Artificial Intelligence Program Manual BG entry 2017 Cellnovo System with Android Joint Development with TypeZero on Artificial Pancreas (License agreement) 2018 Cellnovo Handset replaced by Mobile phone terminal Artificial pancreas CE marking 2019 & beyond

CONT INUOUS GL UCOSE SE NSOR CONT R OL AL GOR IT HM
slide-23
SLIDE 23

Page 23

C o m p a r i s o n Ty p e Z e r o / M e d t r o n i c

  • Founded in 2005, spin-off from UVA
  • In clinical trials since 2011
  • The most published Artificial Pancreas

SW

  • Well-financed by the NIH
  • CGM: G5 Dexcom

Type Zero, a Strong partner TypeZero inControl Medtronic PID-IFB

Paper Ly, Buckingham et al Diabetes Care, 2016 Ly, Buckingham et al DT&T, 2016 Control

24/7 – 85 days and nights Overnight only – 55 nights

Average BG Overnight

128 mg/dl 132 mg/dl

Overnight time within 70-180 mg/dl

90.3% 79.9%

Overnight time within 70-150 mg/dl

76% 66.4%

Overnight time below 70 mg/dl

1.4% 5.4%

24/7 time within 70- 180 mg/dl

78.6% n/a

24/7 time below 70 mg/dl

1.8% n/a

slide-24
SLIDE 24

Agenda

1. A unique technology 2. A company well-placed on COGS 3. An aggressive commercial strategy 4. The next breakthrough: The Artificial Pancreas 5. Financials

slide-25
SLIDE 25

Page 25

K e y F i n a n c i a l s o f t h e G r o u p - S a l e s

  • 832 systems shipped in total since launch with 58 new systems in Q4 2017
  • Production capacity of insulin cartridges constrained, ongoing ramp-up with Flex

Annual Quarterly – 3 months 2017 2016 Q4 2017 Q4 2016 Sales (in K Euros) 1,058 1,417 368.6 363.2 New systems sold (units) 203 405 58 109

At full capacity, Flex’s production line is able to produce 600,000 insulin cartridges per year

  • A cash position of €13,0 million at Dec. 31, 2017

– It doesn’t include any drawdowns from the €20 million loan agreement made with the EIB in July 2017

Progress towards industrial production; sales still limited by capacity

slide-26
SLIDE 26

Page 26

K e y F i n a n c i a l s o f t h e G r o u p – P & L

Simplified P&L in K€ – IFRS

H1 2017 H1 2016

Revenues Sales

473 753

Operating expenses

  • /w Costs of production

(2,902) (3,377)

  • /w Research and Development

(1,591) (1,068)

  • /w Sales & Marketing

(1,457) (540)

  • /w General & Administration

(2,284) (3,252)

Total Operating Expenses

(8,934) (8,237)

Other operating income and expenses

  • Operating profit / (loss)

(8,461) (7,484)

Financial result

(694) (18)

Income tax

463 281

Net profit/(loss)

(8,691) (7,221)

slide-27
SLIDE 27

Page 27

C e l l n o v o o n t h e M a r k e t

Shareholding structure as of July 12, 2017 Financial calendar

  • Market listed on Euronext (Euronext Paris)
  • Share price: €3.32 (Jan. 26, 2018)
  • Market Cap: €56 million (Jan. 26, 2018)
  • Number of shares: 16,746,617

Stock market information

Events Date 2017 FY results and 2018 Q1 sales April 12, 2018 Shareholders’ meeting May 24, 2018 2018 H1 sales and results July 26, 2018 2018 Q3 sales October 11, 2018

Board of Directors

  • John Brooks, Chairman
  • Sophie Baratte, CEO
  • Julie Drapier, Aliad
  • Marie Landel, Independent
  • Sofia Loannidou, censor, Edmond de Rothschild I.P.
  • Raj Parekh, Advent Venture Partners
  • Holger Reithinger, Forbion Capital Partners
  • Rémi Soula, Independent
  • Raphael Wisniewski, Edmond de Rothschild I.P.

Forbion 11,4% EDRIP 11,0% Advent International 6,8% Air Liquide Investissement 3,0% Financière Arbevel 9,7% Others 58,1%